This will be an uncontrolled, open-label, non-randomized, phase I study. The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
160 mg oral once daily BAY 73-4506 for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off)
Unnamed facility
Shatin, N.T, Hong Kong
Unnamed facility
Hong Kong, Hong Kong
Unnamed facility
Singapore, Singapore
Unnamed facility
Singapore, Singapore
Pharmacokinetics as measured by cmax and AUC
Time frame: Cycle 0, Day 1-5,Cycle 1 Day 1,8,15,21,Cycle 2 Day 1,Modified Dosing Cycle Day 21
Adverse Event collection
Time frame: every 1-2 weeks
Objective tumor response rate
Time frame: Every 8 weeks for the first 6 cycles, afterwards every 12 weeks
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